MIAMI and WESTBURY, N.Y., Oct. 28, 2024 /PRNewswire/ -- PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, today announced two significant milestones: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt.
FDA Approval for Omeprazole OTC
The FDA has granted approval for PLD's Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. The product will be manufactured at PLD's facility in Miami, FL, making PLD the only provider of Omeprazole OTC produced in the United States. This achievement underscores the company's extensive capabilities to develop, manufacture, and commercialize some of the most complex products offered in the US consumer healthcare market.
"Receiving FDA approval for Omeprazole OTC is a significant achievement for our organization," said Evan Singer, President of PLD. "This accomplishment not only highlights our team's dedication and expertise in bringing complex products to market, but it also reinforces our role as a comprehensive supply partner for our customers. Our goal is to offer a wide assortment of consumer healthcare products that meet the highest standards of quality and reliability. We are committed to delivering value and consistency to our partners in an ever-evolving marketplace."
The market for Omeprazole OTC in the United States is robust, with retail sales of approximately $550 million annually. PLD expects to commence commercial shipments of Omeprazole to its clients in early 2025.
Corporate Debt Refinancing
In addition to this product milestone, PLD today announces the successful completion of its offer to exchange (the "Exchange Offer") $350,000,000 aggregate principal amount of its outstanding 7.750% Senior Secured Notes due 2025 (the "Old Notes") for new PIK Toggle Senior Secured Notes due 2029 (the "New Notes") in an aggregate principal amount of $368,550,000. This strategic move was made possible through improved financial performance and a collaborative effort with key stakeholders. The completion of the Exchange Offer enhances the company's financial flexibility and positions it for continued growth and strategic investments.
In addition, we previously entered into a commitment letter with certain holders of the Old Notes pursuant to which we expect to issue and sell to such holders in a private transaction additional New Notes in an aggregate principal amount of $131,450,000 (the "Concurrent Financing"). The proceeds from the Concurrent Financing will be used to repay the remaining amounts of Old Notes outstanding and to pay certain fees and expenses in connection with the Exchange Offer and the Concurrent Financing.